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Completed

NCT Number: NCT03472937

Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women

The investigators are performing a randomized controlled trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. The objective of the study is to determine if outpatient compared to inpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing induction shortens the time spent in labor and delivery (from the time of admission to the time of delivery).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

Approximately 20-25% of pregnant women undergo an induction of labor, and a large percentage of these women require cervical ripening in order to "ready" the cervix for induction. In the setting of an unfavorable cervix, induction of labor with oxytocin alone can be associated with longer times to delivery, uterine tachysystole (uterine contractions that are too frequent), and increased rates of cesarean delivery.

Outpatient cervical ripening is an attractive option for both women and their physicians, as this allows for the potential to spend less time in the hospital and more time in the comforts of the patient's own home.

The investigators will conduct a randomized controlled trial comparing outpatient to inpatient cervical ripening using a transcervical Foley catheter. Women will be randomized to undergo inpatient or outpatient transcervical Foley catheter cervical ripening beyond their 39th week of gestation. Women and their infants will be followed until the time of their discharge from the hospital.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18
  • Nulliparous
  • Singleton gestation
  • Gestational age between 39+0 and 42+0 weeks
  • Vertex presentation
  • Modified Bishop score <5 and cervical dilation ≤ 2 cm
  • No prior cesarean or prior uterine surgery
  • Resides within 30 minutes of UAB Hospital
  • Access to a telephone
  • Reliable transportation

Exclusion criteria

  • Unsuitable for outpatient cervical ripening (e.g., IUGR, oligohydramnios, polyhydramnios, gestational hypertension or preeclampsia, complex maternal disease, provider discretion). Patients with well controlled Class A or B DM or chronic hypertension will be eligible.
  • Latex allergy
  • Contraindication to induction of labor
  • Evidence of labor
  • Fetal demise
  • Fetal anomaly
  • Inability to give consent (e.g., inability to read or write)

Treatment and study plan

Transcervical Foley catheter placement for cervical ripening

Procedure

Subjects will be randomized have cervical ripening with a transcervical Foley catheter in either the inpatient or outpatient setting.

Primary outcomes

  1. Total time from admission to delivery

    Time frame: From baseline to the time of delivery (baseline is from admission)

Secondary outcomes

  1. Modified Bishop score on admission

    Time frame: At baseline

  2. Evaluation of patient satisfaction with care

    Time frame: Within 2-4 days after delivery

    Assessed through survey adapted from "Six Simple Questions Survey," which has been published by Harvey et al (Harvey et al. Evaluation of satisfaction with midwifery care. Midwifery. 2002 Dec; 18(4):260-7.) This survey has 6 questions to assess perceptions of satisfaction with care. The questions include questions such as, "I had appropriate and adequate control over my care," "The person(s) responsible for my care are/were caring and compassionate," and "Problems that have arisen up to now have not been dealt with effectively." The scare ranges from 1-7, with 1 representing Strongly Disagree and 7 representing Strongly Agree.

  3. Evaluation of patient experience on labor and delivery

    Time frame: Within 2-4 days after delivery

    Assessed through survey adapted from "Labor and Delivery Index (LADY-X" Survey, which has been published by Gartner et al (Gartner et al. Calculating Preference Weights for the Labor and Delivery Index: A Discrete Choice Experiment on Women's Birth Experiences. Value Health. 2015 Sep; 18(6):856-864.) This survey has 7 questions to assess experiences during labor and birth. Each question then has 3 answer choices that describe how good/poor the experience was. An example of a question is, "Taking your wishes seriously during childbirth." The answers then include "very seriously, sufficiently seriously, or insufficiently seriously."

  4. Evaluation of pain experienced during childbirth

    Time frame: From placement of Foley bulb to delivery

    Assessed through survey that contains 4 questions. The first 3 questions assess pain (worst pain during labor, overall pain during labor, and worse pain during placement of the Foley balloon). The 4th question asks how likely a patient is to recommend her method of induction to a friend/family member. The scale ranges from 0-100, with 0 representing no pain or very unlikely and 100 representing pain as bad as it could possibly be or very likely. The patient is instructed to place a hash mark over the line.

  5. Vaginal bleeding greater than bloody show

    Time frame: From placement of Foley bulb to delivery

    Vaginal bleeding that is like a period or more

  6. Total hospital duration

    Time frame: From hospital admission to hospital discharge (generally less than one week)

  7. Rates of acetaminophen use

    Time frame: From placement of Foley bulb to 24 hours

  8. Rates of calls to the obstetrical triage unit

    Time frame: From placement of Foley bulb to 24 hours

  9. Early admission or early visit to the obstetrical triage unit prior to scheduled induction of labor time

    Time frame: From placement of Foley bulb to 24 hours

  10. Rates of spontaneous rupture of membranes between Foley bulb placement and admission

    Time frame: From placement of Foley bulb to 24 hours

  11. Non-reassuring fetal heart rate tracings 30-minutes after Foley bulb placement

    Time frame: From placement of Foley bulb to 30 minutes

  12. Total duration of time of neuraxial anesthesia use

    Time frame: From baseline to delivery

  13. Total time of oxytocin infusion

    Time frame: From baseline to delivery

  14. Maximum oxytocin rate

    Time frame: From baseline to delivery

  15. Highest maternal intrapartum temperature

    Time frame: From baseline to delivery

  16. Rates of chorioamnionitis

    Time frame: From baseline to delivery

  17. Rates of endometritis

    Time frame: From delivery until 30 days post-discharge

  18. Mode of delivery

    Time frame: From baseline to delivery

    Rates of vaginal delivery, cesarean delivery, and operative vaginal delivery (vacuum or forceps)

  19. Postpartum hemorrhage

    Time frame: At delivery

  20. Rates of hospital readmission within 30 days

    Time frame: From hospital discharge until 30 days post-discharge

  21. Rates of 5-minute Apgar score <7

    Time frame: From time of delivery up to 5 minutes post-delivery

  22. Rates of umbilical cord artery pH <7.1

    Time frame: From time of delivery up to 5 minutes post-delivery

  23. Rates of umbilical cord artery base deficit <-12

    Time frame: From time of delivery up to 5 minutes post-delivery

  24. Rates of neonatal intensive care unit admissions

    Time frame: After delivery and before neonatal discharge (generally less than one week)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women: A Randomized-Controlled Study

Acronym: OFFSITE II

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2018
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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